Come join our diverse team of experts sharing mutual passion and dedication to addressing unmet needs in progressive multiple sclerosis and ALS.
We are running clinical trials across several indications, domestic and internationally. We are seeking a talented and passionate individual that would thrive in a dynamic, fast- paced, team-oriented environment. The Clinical Trial Director will work closely with the Medical Director, Regulatory, and Scientists. The Clinical Trial Director will independently oversee clinical studies from concept to final close and must be a proactive problem-solver with the ability to critically evaluate and manage budget, timelines and key deliverables. Set up of trial sites, local submissions, database oversight, site communications – “making sure the right things are being done and that things are done right.”
NeuroGenesis (www.neurogenesis-cell.com) is a cell therapy company focusing on developing a unique subpopulation of bone marrow cells that are selected and enhanced to become remyelinating bio-factory cells (NG-01). The platform technology is optimized for treating central nervous system diseases such as multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS). The NG-01 technology entails collecting of bone marrow from the patient, then by using a proprietary process, identify and enhance a unique subpopulation of bone marrow cells with outstanding nerve therapeutic properties. NG-01 cells are expanded to tens of millions and injected directly into the spinal cord fluid, home-in on the damaged area, take up residence for up to three months and produce sustained, massive amounts of remyelinating proteins to in-situ remyelinate and repair. NeuroGenesis’ initial focus is on progressive MS. To date, more than 140 patients have been treated with NG-01 via an open label study (Published in Jama Neurology), long term studies (4 years, Frontiers of Neurology), a placebo-controlled trial (Brain, Editor’s Choice) as well as compassionate treatments. Neurogenesis is looking for a cell therapy leader with GMP manufacturing expertise to serve as Director of Manufacturing. This is an exciting opportunity to join Neurogenesis and be part of building the company’s cell therapy manufacturing strategy. The ideal candidate will have expertise in cell therapy manufacturing with a demonstrated track record of successful development-to-clinical product transitions.
Assess internal and external scientific data to better adapt trial designs and interpret trial results
The primary accountability of this role is to enable the manufacturing of cell therapy
products for clinical supply, as a cell therapy technical expert for cGMP manufacturing, through providing hands-on technical leadership and operational oversight for a cell therapy manufacturing facility in Rochester, NY.
We are looking for a candidate with excellent GMP, scientific, technical communication, and leadership skills.